Brain and Central Nervous System TumorsPhase 1NCT00031928
Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
A Phase 1 study testing mafosfamide in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI) at 9 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to determine the effectiveness of mafosfamide in treating patients who have progressive or refractory meningeal tumors. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- mafosfamide
- How many people
- 3,000 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2002to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of leukemia or lymphoma with meningeal involvement defined as cerebrospinal fluid cell count at least 5/mm^3 AND evidence of blast cells on cytospin preparation or by cytology OR
- Diagnosis of other solid tumor with meningeal involvement defined as presence of tumor cells on cytospin preparation or cytology OR presence of measurable meningeal disease on CT or MRI scan
- Meningeal malignancy must be progressive or refractory to conventional therapy
- Meningeal malignancies secondary to an underlying solid tumor are allowed at initial diagnosis provided there is no conventional therapy
- No concurrent bone marrow relapse in leukemia or lymphoma patients
- No clinical evidence of obstructive hydrocephalus or compartmentalization of the cerebrospinal fluid flow as documented by a radioisotope indium In 111 or technetium Te 99-DTPA flow study
- Patients demonstrating restored flow after focal radiotherapy are allowed
PATIENT CHARACTERISTICS:
Age:
- Over 3
Performance status:
- ECOG 0-2
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Not specified
Hepatic:
- No clinically significant liver function abnormalities
Renal:
- No clinically significant renal function abnormalities
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
- No clinically significant metabolic parameter abnormalities (e.g., electrolytes, calcium, and phosphorus)
- No significant systemic illness (e.g., infection)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Recovered from prior immunotherapy
Chemotherapy:
- At least 1 week since prior intrathecal chemotherapy (2 weeks for cytarabine (liposomal)) and recovered
- Concurrent systemic chemotherapy to control systemic or bulk CNS disease allowed with the following exceptions:
- No phase I agent
- No agent that significantly penetrates the CNS (e.g., high-dose systemic methotrexate (more than 1 g/m^2), high-dose cytarabine (more than 2 g/m^2), IV mercaptopurine, fluorouracil, topotecan, or thiotepa)
- No agent known to have serious unpredictable CNS side effects
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- Recovered from prior radiotherapy
- At least 8 weeks since prior craniospinal irradiation
- Local radiotherapy for symptomatic or bulky CNS disease must be given prior to induction therapy
- No concurrent whole brain or craniospinal irradiation
- Concurrent partial brain (e.g., base of brain) or limited-field spinal radiotherapy for asymptomatic bulky (radiographically visible) CNS disease allowed
- Total CNS radiotherapy dose must not exceed accepted safe tissue tolerances
Surgery:
- Not specified
Other:
- At least 1 week since any prior CNS therapy
- At least 7 days since prior intrathecal investigational agent
- At least 14 days since prior systemic investigational agent
- No other concurrent intrathecal or systemic investigational agent
- No other concurrent intrathecal or systemic therapy to treat meningeal malignancy
- No other concurrent intrathecal therapy or agent that significantly penetrates the blood-brain barrier
- No concurrent agent known to have serious unpredictable CNS side effects
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Neurological Research Center, Inc.
Bennington, Vermont, 05201
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202
Texas Children's Cancer Center
Houston, Texas, 77030-2399
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
About this study
Official title: Phase I Study of Intrathecal Mafosfamide
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to determine the effectiveness of mafosfamide in treating patients who have progressive or refractory meningeal tumors.
Read the detailed description
OBJECTIVES:
- Determine the qualitative and quantitative toxicity of mafosfamide in patients with progressive or refractory meningeal malignancy.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the cerebrospinal fluid pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive intrathecal mafosfamide over 20 minutes twice weekly for 6 weeks (induction therapy). Patients then receive intrathecal mafosfamide once weekly for 4 weeks (consolidation therapy), twice a month for 4 months, and then monthly thereafter (maintenance therapy) in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of mafosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3000 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- mafosfamide
- Keywords
- leptomeningeal metastases
- Medical subject headings
- Central Nervous System Neoplasms, Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mafosfamideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Susan M. Blaney, MD, Study chair, Texas Children's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031928
- Sponsor's protocol ID
- CDR0000069240
- Other IDs
- NCI-90-C-0095K, BCM-H-3241
- Status last verified
- Nov 2003
- First submitted
- 8 Mar 2002
- Last updated
- 30 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Intrathecal Mafosfamide
- ClinicalTrials.gov ID
- NCT00031928
- Acronym / sponsor ID
- CDR0000069240
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- leptomeningeal metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 2002
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to determine the effectiveness of mafosfamide in treating patients who have progressive or refractory meningeal tumors.
Detailed description
OBJECTIVES:
- Determine the qualitative and quantitative toxicity of mafosfamide in patients with progressive or refractory meningeal malignancy.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the cerebrospinal fluid pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive intrathecal mafosfamide over 20 minutes twice weekly for 6 weeks (induction therapy). Patients then receive intrathecal mafosfamide once weekly for 4 weeks (consolidation therapy), twice a month for 4 months, and then monthly thereafter (maintenance therapy) in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of mafosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3000 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mafosfamide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan M. Blaney, MD study chair
Texas Children's Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mafosfamide in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI) at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.